Learning Objectives:
At the conclusion of this workshop, participants should be able to:
• Define a common understanding of what a tailored therapeutic is, and is not, and of the terminology used in the field
• Explain successful and unsuccessful case studies illustrating the benefits and pitfalls of tailored therapeutics in drug development and for regulatory applications
• Describe the role and scope of tailored therapeutics in decision making at various stages of the drug development, e.g., patient population selection, clinical trial and program design choices, supporting information for regulatory application, including posthoc examinations of subgroups versus a priori design hypotheses
• Explain the value of collaborative multi-disciplinary interactions as a centerpiece to effectively realize the benefits of tailored therapeutics